What is BS EN ISO 27191-2:2011 ?

What is BS EN ISO 27191-2:2011?

BS EN ISO 27191-2:2011 is a technical standard published by the British Standards Institution (BSI) that outlines the requirements for the implementation of a quality management system in the manufacturing industry. This standard is designed to ensure that organizations involved in the production of medical devices, including medical device manufacturers, quality assurance organizations, and regulatory affairs departments, follow best practices to meet customer and regulatory requirements.

What is EN ISO 27194:2011?

EN ISO 27194:2011 is a technical standard published by the European Committee for Standardization (CEN) that provides guidelines for the implementation and operation of a quality management system for medical devices. This standard is intended to establish a framework for a quality management system that focuses on the specific needs of the medical device industry.

EN ISO 27194:2011 aims to help medical device organizations ensure that their products meet customer and regulatory requirements, while also enhancing their ability to consistently provide safe and effective medical devices that meet customer expectations. Compliance with EN ISO 27194:2011 also helps manufacturers demonstrate their commitment to quality and regulatory compliance, which is crucial for market access and customer trust.

What is EN ISO 27294:2011?

EN ISO 27294:2011 is an international standard published by the CEN that provides guidelines for the implementation and operation of a quality management system for technical product documentation. This standard outlines the requirements for creating, organizing, and delivering product information throughout its entire lifecycle.

The main purpose of EN ISO 27294:2011 is to ensure that technical product documentation meets the needs of end-users, customers, and other stakeholders. By following this standard, organizations can effectively manage their product information from initial design and development stages to final disposal.

Key Requirements of EN ISO 27294:2011

In order to be compliant with EN ISO 27294:2011, organizations must ensure that they have a defined quality management system in place that meets the requirements outlined in the standard. This system should include the following key requirements:

Documentation: Technical product documentation should be complete, accurate, and up-to-date.

Controls: Organizations should have controls in place to ensure that their quality management system is being followed and that they are able to demonstrate compliance with the standard.

Management: The organization should have a clear understanding of its quality management system and how it will be managed.

Continuous Improvement: The organization should be committed to continuous improvement and should have a plan in place for monitoring and improving their quality management system.

Monitoring: The organization should have a system in place for monitoring and measuring the effectiveness of their quality management system.

Reporting: The organization should be able to report on their quality management system and their compliance with the standard.

Conclusion

EN ISO 27191-2:2011, EN ISO 27294:2011, and EN ISO 27194:2011 are all important standards that help organizations ensure that their medical device products meet customer and regulatory requirements. By implementing these standards, organizations can enhance their ability to consistently provide safe and effective medical devices that meet customer expectations. Compliance with these standards also helps manufacturers demonstrate their commitment to quality and regulatory compliance, which is crucial for market access and customer trust.